Long-time quality assessment of the Elecsys Troponin T hs assay

Ola Hammarsten; Carl-Eric Jacobsson; Monica Widegren; Tatyana Danylchenko; Allan S Jaffe

doi:10.1016/j.clinbiochem.2013.03.022

Long-time quality assessment of the Elecsys Troponin T hs assay

Clin Biochem. 2013 Aug;46(12):1055-1057. doi: 10.1016/j.clinbiochem.2013.03.022. Epub 2013 Apr 9.

Authors

Ola Hammarsten¹, Carl-Eric Jacobsson², Monica Widegren², Tatyana Danylchenko², Allan S Jaffe³

Affiliations

¹ Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska University Hospital at Sahlgrenska Academy, University of Gothenburg, S-413 45 Gothenburg, Sweden. Electronic address: ola.hammarsten@clinchem.gu.se.
² Department of Clinical Chemistry and Transfusion Medicine, Sahlgrenska University Hospital at Sahlgrenska Academy, University of Gothenburg, S-413 45 Gothenburg, Sweden.
³ Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN, USA; Division of Cardiovascular Diseases, Department of Laboratory, Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.

PMID: 23578743
DOI: 10.1016/j.clinbiochem.2013.03.022

Abstract

Recently, Roche announced a problem with the calibrators for their high sensitive cardiac troponin T (hscTnT) assay. We have monitored the performance of the assay since its introduction into clinical use in December 2009 and we're in a unique position to provide quantitative information concerning the effects of this problem. Our data document that the measured cTnT concentration in the hscTnT assay dropped by 5.8 ng/L around the 99th percentile before its recalibration in May 2012. Thus, the hscTnT levels in our hospital have been underestimated around this cut-off value since its introduction. The approach we used may be one that other laboratories should consider.

Keywords: Calibration; High sensitive troponin assays.

MeSH terms

Calibration
Chemistry, Clinical / methods*
Humans
Quality Assurance, Health Care*
Sensitivity and Specificity
Time Factors
Troponin T / blood*

Substances

Troponin T